NCT01941394Unknown2 期
Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- GVHD
研究概览
简要总结
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.
详细描述
Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •allogenic BMT from related or unrelated donor
排除标准
- •Severe infection
- •admission to ICU
- •refusal of research
- •patients with graft failure
研究组 & 干预措施
With MSC
Experimental
infusion of Mesenchymal stem cells at dose 1 mln cells per kg
干预措施: Mesenchymal stem cells (Biological)
结局指标
主要结局
GVHD
时间窗: Every 30 day for 1 year after BMT
次要结局
- Overall survival(Every 30 day for 1 year after BMT)
- Relapse-free survival(Every 30 day for 1 year after BMT)
- Infection rate(Every 30 day for 1 year after BMT)
研究者
Elena N.Parovichnikova
Head of BMT department
National Research Center for Hematology, Russia
研究点 (1)
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